The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
≥75% improvement in facial Vitiligo Area Scoring Index.
Time frame: Week 24
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
≥50% improvement in facial Vitiligo Area Scoring Index.
Time frame: Week 24
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
≥90% improvement in facial Vitiligo Area Scoring Index.
Time frame: Week 24
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)
≥50% improvement in total body Vitiligo Area Scoring Index.
Time frame: Week 24
Percentage change from baseline in F-BSA
Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.
Time frame: Week 24
Number of Treatment Emergent Adverse Events (TEAEs)
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time frame: Up to Week 52 and 30 days
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
≥50% improvement in facial Vitiligo Area Scoring Index.
Time frame: Week 52
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University of Alabama At Birmingham-School of Medicine
Birmingham, Alabama, United States
NOT_YET_RECRUITINGPhoenix Children'S Hospital
Phoenix, Arizona, United States
RECRUITINGOmni Dermatology
Phoenix, Arizona, United States
NOT_YET_RECRUITINGAffiliated Dermatology
Scottsdale, Arizona, United States
COMPLETEDBanner - University Medicine Multispecialty Services Clinic
Tucson, Arizona, United States
RECRUITINGPremier Dermatology Clinical Trials Institute At Northwest Arkansas
Fayetteville, Arkansas, United States
RECRUITINGBurke Pharmaceutical Research
Hot Springs, Arkansas, United States
RECRUITINGAxon Clinical Research
Inglewood, California, United States
RECRUITINGUniversity of California Irvine
Irvine, California, United States
RECRUITINGVitiligo & Pigmentation Institute of Southern California
Los Angeles, California, United States
RECRUITING...and 89 more locations
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)
≥75% improvement in facial Vitiligo Area Scoring Index.
Time frame: Week 52
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
≥90% improvement in facial Vitiligo Area Scoring Index.
Time frame: Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)
≥50% improvement in total body Vitiligo Area Scoring Index.
Time frame: Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25)
≥25% improvement in total body Vitiligo Area Scoring Index.
Time frame: Week 24 and Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)
≥75% improvement in total body Vitiligo Area Scoring Index
Time frame: Week 24 and Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)
≥90% improvement in total body Vitiligo Area Scoring Index
Time frame: Week 24 and Week 52
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations
Trough is defined as the concentration reached by a drug immediately before the next dose is administered.
Time frame: Weeks 6, 24, 30 and 52